DECOLORIZED IODINE- ethyl alcohol liquid

Decolorized Iodine by

Drug Labeling and Warnings

Decolorized Iodine by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Humco Holding Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Ethyl Alcohol 48%

Purpose

First Aid Antiseptic                        

Use

first aid to help prevent infection in minor cuts, scrapes and burns.

Warnings

For external use only

Flammable, keep away from fire or flame

When using this product 

do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

Stop use and consult doctor if the

condition persists or gets worse. Do not use this product for longer than 1 week unless directed by a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Clean the affected area.
  
• apply a small amount on the area 1 to 3 times daily.
  
• may be covered with sterile bandage.
  
• if bandaged, let dry first.

Other information 

store at room temperature

Inactive ingredients

ammonium hydroxide, iodine, potassium iodide, and purified water

PRINCIPAL DISPLAY PANEL

NDC: 37205-648-16
Leader ®
Decolorized Iodine
Alcohol 48%
FIRST AID ANTISEPTIC
For External Use Only
2 FL OZ (59 mL)

INGREDIENTS AND APPEARANCE

DECOLORIZED IODINE 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-648
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	48 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
AMMONIA (UNII: 5138Q19F1X)
IODINE (UNII: 9679TC07X4)
POTASSIUM IODIDE (UNII: 1C4QK22F9J)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-648-16	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/1979

Labeler - Cardinal Health (097537435)

Registrant - Humco Holding Group, Inc. (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc.		825672884	analysis(37205-648) , manufacture(37205-648) , pack(37205-648) , label(37205-648)